市售導尿管安全性及功能性檢驗方法之建立

Investigation of the Safety and Efficacy of Foley Catheter in Taiwan

導尿管（Foley catheter）上市後不良品通報，以球囊的不良反應最多，包含滲漏導致導尿管滑脫，或水分移除有異致使導尿管取出困難；另外則有導尿管阻塞扭結（kink）等情況。本研究參考ASTM F623、EN 1616及JIS T 3214等國際標準及泌尿導管臨床前測試基準並蒐集彙整相關文獻資料，建立導尿管安全性及功能性檢驗方法。其測試項目包括導尿管強度、連接牢固性、球囊可靠度（球囊完整性及回收率）、導尿管流量及扭結測試。利用所建立之方法檢測市售計6件檢體，結果導尿管強度、連接牢固性、球囊完整性、回收率、導尿管流量皆符合標準規範要求，扭結測試評估則落在9.7－11.1％。 In order to assure the quality of the Foley catheter in Taiwan market, a survey focused on the strength, connector security, balloon security, flow rate, and kink stability was conducted in 2017. There were 6 silicon balloon retention type Foley catheters collected from authorized medical device dealers. The strength, connector security and balloon security tests were carried out in accordance with EN 1616. The flow rate and kink stability tests were conducted in accordance to ASTM F623. The results showed that all samples met the strength, connector security, and balloon security test requirements, as well for their flow rate fulfilled the regulatory requirement (above 100 cm^3/min). The kink stability tested was between 9.7 - 11.1%. These results will be forwarded to the competent authorities as regulatory references.